Description

Medetomidine Impurity 36 is a high-purity chemical reference standard used in analytical research and pharmaceutical development. This compound is critical for the quality control and regulatory compliance of Medetomidine, an important sedative and analgesic agent used in veterinary medicine. It serves as an essential tool for researchers and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) to ensure product purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Medetomidine Impurity 36 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity isolation, characterization, and toxicological studies during the drug development process.

Basic Information

Product Name	Medetomidine Impurity 36
CAS No.	2128719-74-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Medetomidine Related Compound 36; Medetomidine EP Impurity 36; Medetomidine USP Impurity 36; Dexmedetomidine Impurity 36; (S)-Medetomidine Impurity 36; 4-[1-(2,3-Dimethylphenyl)ethyl]-1H-imidazole Impurity 36; Precedex Impurity 36
EINECS	Contact for details

Quality Control

Every batch of Medetomidine Impurity 36 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.